Impact of Surgical Timing on the Neurodevelopmental Prognosis of Newborns With Complex Congenital… (NCT04733378) | Clinical Trial Compass
UnknownNot Applicable
Impact of Surgical Timing on the Neurodevelopmental Prognosis of Newborns With Complex Congenital Heart Disease
France50 participantsStarted 2021-12-24
Plain-language summary
We propose a prospective observational study whose main objective will be to determine whether there is an association between age at surgery (days of life) and neurodevelopmental outcome in patients with CCHD. Secondly, we will study the relationship between age at surgery and (i) the incidence of WMI observed on pre- and post-operative cerebral MRI (ii) post-operative morbidity as defined by the occurrence of post-operative complications (haemodynamic, infectious, neurological, surgical) and (iii) the length of hospital stay.
Who can participate
Age range
0 Months – 2 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
* Patients aged 2 months or less with complex congenital heart disease (CCHD) requiring surgery with cardiac circulation during their first 2 months of life
* Eligible heart diseases: Transposition of the Large Vessels (TGV), hypoplasia of the left ventricle, right ventricle with double outlet type Fallot or TGV, obstruction of the aortic arch, truncus arteriosus, atrioventricular duct, pulmonary atresia with or without communication inter ventricular.
* Informed consent signed by both parents
* Patient affiliated to health social security
Non-inclusion criteria:
* patients with a birth weight less than 2 kilograms and / or a gestational age less than 37 weeks
* patients with a CCHD not requiring cardiac surgery with extra-corporeal circulation in the first 2 months of life
* patients with a chromosomal abnormality or genetic syndrome proven associated with CCHD
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of the association between age at surgery (days of life) and scores (mean = 100, standard deviation = 15) obtained on the Bayley II test